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Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21/R33 - Clinical Trial Optional)

PAR
Friday, September 13, 2019
Friday, December 4, 2020
R21/R33
PAR-19-376

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage exploratory/developmental research applications that propose to study the development, validation, feasibility, and effectiveness of innovative mobile health (mHealth) interventions or tools specifically suited for low- and middle-income countries (LMICs) that utilize new or emerging technology, platforms, systems, or analytics. The overall goal of the program is to catalyze innovation through multidisciplinary research that addresses global health problems, develop an evidence base for the use of mHealth technology to improve clinical and public health outcomes, and strengthen mHealth research capacity in LMICs. Applicants are required to propose partnerships between at least one U.S. institution and one LMIC institution.

Mechanistic Basis of TDP-43-dependent Pathobiology in Common Dementias (R01 Clinical Trial not Allowed)

RFA
Thursday, September 5, 2019
Saturday, November 16, 2019
R01
RFA-NS-20-005

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to support hypothesis-testing research on the systems, cellular and/or molecular mechanisms and consequences of TDP-43 proteinopathy in common dementias using whole animal models, animal/human cellular model systems, as well as postmortem tissue and other biospecimens. Research on TDP-43 proteinopathy in common dementias, including the clinical syndrome of Alzheimer's disease (AD), multiple etiology dementias (MED) and related dementia syndromes is the focus of this FOA. In addition, comparative studies of TDP-43 proteinopathy in common and rare neurodegenerative diseases, as well as during normal aging and in pre-symptomatic disease stages are within scope.

Peripheral Pathology in the Lewy Body Dementias (R01 Clinical Trial Not Allowed)

RFA
Thursday, September 5, 2019
Wednesday, December 4, 2019
R01
RFA-NS-20-014

Funding Opportunity Purpose

The purpose of this initiative is to identify potential biomarkers for the Lewy Body Dementias using non-blood or CSF peripheral specimens and tissues (e.g., autonomic nervous system, skin, salivary gland, GI tract/microbiome, olfactory mucosa, etc.). Blood and CSF have traditionally and extensively been examined for neurodegenerative disease biomarkers; however, research suggests that abnormal alpha-synuclein accumulation occurs in other peripheral tissues and specimens pre-symptomatically and may provide opportunities for early diagnosis and future treatment development.

Clinical Sites for the ECHO IDeA States Pediatric Clinical Trials Network - 2 (UG1 Clinical Trial Required)

RFA
Friday, August 30, 2019
Tuesday, December 3, 2019
UG1
RFA-OD-19-026

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA), issued by the Office of the Director (OD), National Institutes of Health (NIH), is to invite applications from entities/institutions in Institutional Development Award (IDeA)-eligible States to participate in the Environmental Influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN) as a Clinical Site. The Clinical Sites of the ISPCTN will: --Conduct multicenter clinical trials research, assuring the participation of children living in rural or underserved communities located in Institutional Development Award (IDeA) states. --Build pediatric research capacity for IDeA states to support the conduct of clinical trials of relevance to rural or underserved children in IDeA states.

Data Coordinating and Operations Center for the ECHO IDeA States Pediatric Clinical Trials Network - 2 (U24 - Clinical Trial Required -Infrastructure)

RFA
Friday, August 30, 2019
Tuesday, December 3, 2019
U24
RFA-OD-19-025

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA), issued by the Office of the Director (OD), National Institutes of Health (NIH), is to invite applications from entities/institutions in Institutional Development Award (IDeA)-eligible States to participate in the Environmental Influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN) as the Data Coordination and Operations Center (DCOC). The DCOC will support the Clinical Sites of the ISPCTN to: --Conduct multicenter clinical trials research, assuring the participation of children living in rural or underserved communities located in Institutional Development Award (IDeA) states. --Build pediatric research capacity for IDeA states to support the conduct of clinical trials of relevance to rural or underserved children in IDeA states.

The NINDS Human Cell and Data Repository (U24 - Clinical Trial Not Allowed)

RFA
Friday, August 30, 2019
Wednesday, October 23, 2019
U24
RFA-NS-19-038

Funding Opportunity Purpose

Reissue of RFA-NS-15-009. This Funding Opportunity Announcement (FOA) invites applications to support the National Institute of Neurological Disorders and Stroke (NINDS) Human Cell and Data Repository (NHCDR). The repository will maintain the current collection of fibroblast and induced pluripotent stem cell (iPSC) lines as well as develop, characterize, expand source cells and iPSCs, and where appropriate, genetically modify new high-quality iPSC lines accordance with the NINDS mission. The NINDS Human Cell and Data Repository will distribute human cell resources broadly to qualified academic and industry researchers to advance basic and translational research in neurological disorders.

Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)

RFA
Wednesday, August 14, 2019
Saturday, October 19, 2019
UG3/UH3
RFA-HL-20-030

Funding Opportunity Purpose

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials. This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications are expected to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans. Successful applicants proposing the use of adult stem cells as a clinical intervention will be asked to make available representative samples of the source stem cell and clinical-grade stem cell-derived product for in-depth and independ

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance (SB1, R44) Clinical Trial Not Allowed

PAR
Monday, August 5, 2019
Wednesday, April 6, 2022
SB1
PAR-19-334

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA aims to facilitate the transition of previously funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance not typically supported through Phase II or Phase IIB grants or contracts. This may include preparation of documents for a Food and Drug Administration (FDA) submission, development of an intellectual property strategy, and/or planning for a clinical trial. Although a significant amount of the work in a CRP award may be subcontracted to other organizations, the SBC is expected to maintain oversight and management of the R and D throughout the award. Clinical trials not accepted under this FOA.

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, R44) Clinical Trial Not Allowed

PAR
Monday, August 5, 2019
Wednesday, April 6, 2022
SB1
PAR-19-333

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA aims to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance and later stage research and development (R and D) not typically supported through Phase II or Phase IIB grants or contracts. This may include independent replication of key studies, Investigational New Drug (IND)-enabling studies, clinical studies, manufacturing costs, regulatory assistance, or a combination of services. Although a significant amount of the work in a CRP award may be subcontracted to other institutions, the Small Business Concern (SBC) is expected to maintain oversight and management of the R and D throughout the award.

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, R44) Clinical Trial Required

PAR
Monday, August 5, 2019
Wednesday, April 6, 2022
SB1
PAR-19-335

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA aims to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance and later stage research and development (R and D) not typically supported through Phase II or Phase IIB grants or contracts. This may include independent replication of key studies, Investigational New Drug (IND)-enabling studies, clinical studies, manufacturing costs, regulatory assistance, or a combination of services. Although a significant amount of the work in a CRP award may be subcontracted to other institutions, the Small Business Concern (SBC) is expected to maintain oversight and management of the R and D throughout the award.

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